Etubics Corporation, a biopharmaceutical company developing "next generation" vector vaccines, has entered into Phase I trials at Duke University with its ETBX-011, a therapeutic vaccine candidate that is intended to treat Carcinoembryonic Antigen (CEA)-expressing cancers such as colorectal cancer. Etubics dosed its first patient yesterday. Etubics was recently granted clearance by the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to begin studying ETBX-011 in humans.

Michael Morse, M.D. at Duke Comprehensive Cancer Center noted, "Etubics' novel vector vaccine approach activates cell mediated immunity and antibodies against cancers that express CEA. We look forward to studying this vaccine candidate in patients with cancers that express CEA."

Etubics ETBX-011 utilizes a novel adenovirus serotype 5 (Ad5) vector platform technology, called Ad5 [E1, E2b-]-CEA. CEA represents an attractive target antigen for immunotherapy since it is over-expressed in nearly all colorectal cancers. When tested against a conventional Ad5 platform, Etubics' vaccine induced a significantly greater T-cell immune response in mice. Ad5 vectors have been used extensively in clinical studies but have been presented with the challenge of the patient's own immunity against the vaccine itself. Pre-clinical data suggests that ETBX-011 may break through this barrier to induce an immune response.

H. Kim Lyerly, M.D., Director of Duke Comprehensive Cancer Center noted, "We have been researching immunotherapy for cancer patients for many years, and Etubics' drug platform may provide us with another option for delivering tumor associated antigens for immunotherapy of our cancer patients in the future. We look forward to better understanding the potential for this candidate as a result of this preliminary study."

Frank Jones, Ph.D., founder, Chairman and Chief Executive Officer of Etubics stated, "This FDA clearance of the IND for Etubics' next generation vectored vaccine candidate for CEA expressing cancers marks an important step for Etubics. We look forward to the day that Etubics therapeutic vaccine is widely available to treat these cancers and remain committed to bringing this new drug through the FDA licensing process."

Etubics Phase I CEA trial is funded through grants from the National Cancer Institute (NCI). For more information on this trial, visit ClinicalTrials. A full press release can be found here.